Glaucoma After Congenital Cataract Surgery

May 27, 2021 updated by: Haotian Lin, Sun Yat-sen University
To determine the incidence of glaucoma following bilateral congenital cataract removal and estimate the associated risk factors in a large cohort to provide guidance for clinical practice.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2025 was performed.

Study Type

Observational

Enrollment (Anticipated)

351

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital cataracts was performed.

Description

Inclusion Criteria:

  • a diagnosis of bilateral congenital cataracts, the etiologies include congenital idiopathic cataract and congenital cataract associated with a systemic syndrome or ocular anomalies;
  • cataract surgery performed in ZOC;
  • age at cataract removal younger than 16 years;

Exclusion Criteria:

  • the preoperative IOP was above 21 mm Hg;
  • family history of glaucoma;
  • signs of preoperative glaucoma were present, such as corneal clouding, corneal enlargement, excessive cup-disc ratio and myopic shift;
  • ocular trauma history;
  • previous surgery intervention and
  • they were noncompliant with our follow-up protocol to monitor the occurrence of glaucoma and glaucoma suspect.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of glaucoma after congenital cataract surgery
Time Frame: baseline
A Kaplan-Meier analysis was used
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors of glaucoma after congenital cataract surgery
Time Frame: baseline
Piecewise exponential survival models with mixed effects (PEWSMME) were used.(variables including demographic characters, surgery categories, clinical history, length of follow up).
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

April 8, 2020

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCPMOH2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glaucoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe